E & E Medicals and consulting
About E & E Medicals and consulting
When one considers a group of knowledgeable and experienced professional engineers, medical device and pharmaceutical regulatory consultants, quality assurance and reliability experts, merged with a talented sales team dedicated to online medical supplies, what you get is E & E Medicals and Consulting. We have well-established partners in the EU, Asia, and USA.We have the most exceptional access to a team of consultants who are very experienced with the U.S. Food and Drug Administration (FDA) and the healthcare industry. E& E Medicals provides the following services: Medical Device and Diagnosticso Investigational Device Exemption (IDE)o Premarket Notification 510(k), DeNovo, PMAo Establishment Registrationo US Agent for Foreign EstablishmentsDrugs / Biologics / Pharmacovigilanceo Investigational New Drug (IND) Applicationo New Drug Application(NDA)o Abbreviated New Drug Application (ANDA)o Biologics License Application (BLA)o Drug Master File (DMF) Submissionso Chemistry, Manufacturing, and Control (CMC)International Regulations, Approvals, Licensing and Complianceo CCC Mark Approvalo CE Mark Approvalo EU MDR/IVDR Technical Documentationo Post-market Complianceo FDA 483 Warning Letter/Recalls and Remediationo Canada License Applicationso Regions: APAC, LATAM, EMEA, ASEAN, METAHEALTHCARE CONTINUOUS IMPROVEMENTo Reliabilityo Six Sigma - HealthcareQUALITY ASSURANCEo Medical Deviceso Auditso Reliabilityo Quality System Regulationo Quality Management System ImplementationQUALITY SYSTEMS IMPLEMENTATION, ISO CERTIFICATION o ISO 13485 Quality System Registrationo ISO 14971 Device Risk Managemento ISO 9001 Quality Management Systemo Free ISO 13485:2016 Gap Analysis Toolo Free ISO 9001:2015 Gap Analysis Tool
Company Metrics
- Employees: 1-10
- Monthly Visits: None
- Tech Stack: None active products
Financial Information
- Estimated Revenue: $1M to $10M
- Total Funding: None None
- Last Funding: None None (None)
- Funding Status: None
Technology Stack
E & E Medicals and consulting actively uses None products in their tech stack.
Market Presence
Industries: Mechanical or industrial engineering, Ce mark approval, Denovo, New drug application, Abbreviated new drug application
Headquarters: Atlanta, Georgia